Method of performing a suprapubic transurethral cystostomy and associated procedures and apparatus therefor

ABSTRACT

A suprapubic transurethral cystotomy apparatus and method of forming a surgical opening therewith. The apparatus includes an elongate tubular body including a proximal portion and a distal portion inclined relative to one another. The distal portion extends along an axis to an end configured for receipt through a urethra. An elongate arm has a first end operably attached to the proximal portion of the tubular body and a second end providing an indicator establishing an axis aligned coaxially with the axis of the distal portion. A surgical opening is formed with a cutting member being extended along the axis of the indicator.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 60/975,548, filed Sep. 27, 2007, and U.S. Provisional ApplicationSer. No. 61/038,457, filed Mar. 21, 2008, both of which are incorporatedherein by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Technical Field

This invention relates generally to methods and apparatus for forming asurgical opening and providing guidance for an instrument while inside abody cavity with an external guidance apparatus, and more particularlyto methods and apparatus for performing a transurethral (inside-out)suprapubic cystostomy, associated urological procedures and othersurgical procedures.

2. Related Art

It is well known in the medical profession that many people experiencebladder emptying problems (either urinary retention, or urinaryincontinence). When severe, both conditions require drainage with acatheter. There are various factors that contribute to bladder outletobstruction/urinary retention (BOO), such as, complications resultingfrom surgery, diseases, injuries, and aging. Some conditions requireonly a temporary solution, while others may require a more permanentsolution. In addition to the open surgery method of placing a catheter,there are three known methods currently used to resolve urinaryretention problems. The first method is known as clean intermittentself-catheterization (CISC). As the name suggests, this method isperformed by the patient, using a clean but typically non-steriletechnique 3 to 4 times daily. The patient inserts a catheter into theirbladder through the urethra at regular intervals over the course of theday. Although this is presently believed to be the preferred method, itcan be painful, awkward, depending on available privacy, and otherwisedifficult, particularly for modest, elderly and/or incapacitatedpersons. In addition, complications such as urethral perforation,bladder perforation or stricture formation can occur, particularly inmen, and urinary tract infections (UTI) often result from performing theprocedure as the procedure is generally “clean” but not sterile.

The second method, and believed to be the most commonly used, is knownas a urethral Foley catheterization (UFC). In this process, a physicianor nurse inserts a Foley catheter into the bladder through the urethra.The Foley catheter has an internal balloon near its tip that is inflatedto maintain the catheter within the bladder. Although this method is themost commonly used, it has many potential problems. With this method,urinary tract infections occur generally at a rate of 3-10 percent perday with an indwelling catheter maintained within the bladder, withabout 5 percent of the patients developing bacterial blood infections(bacteremia).

The third method is known as a suprapubic cystostomy (SPC), and itincludes two different types of procedures that are performed by aurologist usually employing intravenous (IV) sedation or localanesthesia while usually under hospital care. These procedures can beperformed as a standalone procedure or in conjunction with another inunrelated surgical procedures. The first procedure is commonly referredto as a percutaneous or “outside-in” trocar punch procedure, and thesecond procedure is conversely referred to as a transurethral(“inside-out”) or endocystostomy procedure. The SPC methods arepredominantly used in the U.S. when long-term drainage is desired, andit is used internationally for both short and long-term drainage. Thepercutaneous punch “outside-in” procedure is by far the more commonlyused method of the two, and it entails inserting a large bore hollowneedle through the abdomen and then into the bladder. This procedurerequires the bladder to be inflated or distended with water to create afirm abdomen to push against while inserting the hollow bore needle dueto tissue resistance. The percutaneous punch method whereby a hollowneedle is pushed through the abdomen into the bladder is a blindprocedure and relies on physical feel and skill and experience of thephysician to safely puncture the bladder. Thereafter, a smaller catheteris inserted through the hollow needle into the bladder. Drawbacks tothis method include unreliable drainage due to a high rate of cloggingand kinking of the catheter drainage tube. The percutaneous punch methodhas increased safety issues with high morbidity and mortality rate near2%, usually from unrecognized puncturing of bowel. These two procedurescannot be safely performed on the morbidly obese patient, a patientpopulation that is increasing, currently estimated to be more than 12percent of this targeted patient population.

The current transurethral (“inside-out”) procedure is performed byinserting a hollow instrument with a blunt tip, commonly referred to asa sound, through the urethra into the bladder. The Sound has a tip thatis typically advanced to penetrate through the bladder and abdominalwall and extend outside the abdomen. The surgeon is usually required tomake an incision in the abdomen and facia, down to the tip of the soundto allow the blunt tip of the sound to advance through the abdomenexiting the skin. In the cases where the sound tip cannot reach outsidethe abdomen, the surgeon must make a larger incision in the abdomen witha scalpel to allow for attachment of the catheter while the sound tipresides inside the abdomen. With the sound finally exposed outside theabdomen, a catheter is attached to the end of the sound and drawn backinto the bladder and out of the patient through the urethra along withthe withdrawn sound. Upon being pulled and exiting the patient throughthe urethra, the catheter is then detached from the sound and pulledback into the bladder, whereupon a balloon on the catheter is inflatedin an effort to maintain the catheter in a desired position within thebladder. Some of the drawbacks to this method include, a relatively highcost of the reusable surgical instruments, requiring sterilizationbetween procedures, the catheter can be difficult to attach to the soundand once attached can disconnect during the procedure requiring theprocedure to be repeated, the location of the deflated catheter balloonwithin the bladder can be difficult to ascertain prior to inflating thecatheter balloon, and additionally, it can often not be effectively usedto safely perform the procedure on obese and morbidly obese patients.

SUMMARY OF THE INVENTION

A suprapubic transurethral cystotomy apparatus includes an elongatetubular body having a length including a proximal portion and a distalportion inclined relative to one another. The distal portion extendsalong an axis to an end configured for receipt through a urethra. Theapparatus further includes an elongate arm having a first end operablyattached to the proximal portion of the tubular body and a second endproviding an indicator aligned coaxially with the axis of the distalportion.

According to another aspect of the invention, a method of forming asurgical opening extending through an abdominal wall and into a bladderis provided. The method includes providing an elongate tubular bodyhaving a proximal portion and a distal portion and inserting the distalportion through a urethra and into the bladder. Further, providing anelongate arm having a first end and a second end having an indicatorestablishing an axis and operably attaching the first end of the armwith the proximal portion of the tubular body and positioning theindicator externally over the abdominal wall with the axis arranged incoaxial alignment with the distal portion of the tubular body. Then,puncturing an opening with a cutting member extending along the axisthrough the bladder and through the abdominal wall.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of the invention willbecome more readily appreciated when considered in connection with thefollowing detailed description of presently preferred embodiments andbest mode, appended claims and accompanying drawings, in which:

FIG. 1 is a perspective view of a transurethral suprapubic cystostomyapparatus constructed in accordance with one presently preferredembodiment of the invention;

FIG. 2 is a cross-sectional side view of the apparatus;

FIG. 3 is an enlarged cross-sectional side view of a rear handle of theapparatus of FIG. 1;

FIG. 4 is an enlarged fragmentary perspective view of a rear handle ofthe apparatus of FIG. 1;

FIG. 5 is an enlarged cross-sectional side view of a front handle shownin a locked position;

FIG. 6 is an enlarged cross-sectional side view of the front handleshown in an unlocked position;

FIG. 7 is an enlarged side view of a cutting tip attached to a collet ofan advancement rod of the apparatus of FIG. 1;

FIG. 8 is a side view of a urethra and bladder showing a sound of theapparatus inserted therein;

FIG. 9 is a view similar to FIG. 8 showing an alignment guide arm andcapture cup of the apparatus positioned above an abdominal wall;

FIG. 10 is a side view showing the capture cup lowered into contact withthe abdominal wall;

FIG. 11 is a side view showing a penetration depth marker of theapparatus moved adjacent an opening of the urethra;

FIG. 12 is a side view showing the cutting tip penetrating the bladderand abdominal wall;

FIG. 13 is a broken away side view showing the cutting tip fullypenetrated through the bladder and abdominal wall and received in thecapture cup;

FIG. 13A is an enlarged cross-sectional view of the capture cup showingthe cutting tip attached to the advancement rod and captured in thecapture cup;

FIG. 13B is an enlarged cross-sectional view of the capture cup showingthe capture cup and the cutting tip removed from the advancement rod andcaptured in the capture cup;

FIG. 14 is a side view showing a catheter about to be attached to thesound via the collet of the advancement rod with the catheter drawnpartially through the abdominal wall;

FIG. 14A is a perspective view of the catheter with a removal toolinserted therein;

FIG. 14B is an enlarged perspective view of a distal end of thecatheter;

FIG. 14C is an enlarged perspective view of an end of the catheter witha shroud removed from the end;

FIG. 14D is an enlarged cross-sectional view of a drainage end of thecatheter;

FIG. 14E is a view similar to FIG. 14D with a removal tool inserted intothe end;

FIG. 14F is a perspective view of the removal tool;

FIG. 15 is a view similar to FIG. 14 showing the catheter drawn into thebladder and the alignment guide arm removed from the sound;

FIG. 16 is a view similar to FIG. 15 showing a balloon of the catheterinflated;

FIG. 17 is a view similar to FIG. 16 showing the inflated balloon drawnback into abutment with the bladder wall; and

FIG. 18 is a view similar to FIG. 17 showing the catheter detached fromthe collet of the advancement rod and the sound being withdrawn from theurethra.

DETAILED DESCRIPTION OF PRESENTLY PREFERRED EMBODIMENTS

Referring in more detail to the drawings, FIGS. 1 and 2 illustrate asuprapubic transurethral cystostomy apparatus 10 constructed inaccordance with one aspect of the invention. It should be recognizedthat other embodiments that perform a similar function, in a generallysimilar way, are contemplated to be within the scope of the invention.For example, the apparatus 10 and its associated individual componentscan be modified, while having a generally similar construction, and canbe further modified to accommodate any size male or female, adult orpediatric patient, including obese and morbidly obese patients. Ofcourse, it will be recognized by those skilled in the art that femaleand male organs, particularly the urethra, are shaped differently andhave differing lengths and diameters, and so, the construction of theapparatus 10 can be varied to accommodate those differences. Theapparatus 10 includes an elongate hollow tubular body, generallyreferred to as a sound 12, and an alignment structure which includes analignment guide arm 14 and a mast 42, adapted for operable attachment tothe sound 12 in a predetermined position relative to the sound 12. Thesound 12 is configured for insertion through a urethra 16 into a bladder18, while the alignment guide arm 14 remains outside the patient toindicate the precise exit location of a trocar, referred to hereafter ascutting tip 20, extending from the sound 12 through an abdominal wall 22of the patient. In addition to indicating the precise exit location ofthe cutting tip 20 through the abdominal wall 22, the alignment guidearm 14 can be positioned to abut the abdominal wall 22 to provide aclamping action against the abdominal wall 22, thereby holding theinstrument in place and providing tensile reinforcement of the patient'ssurface skin to allow the cutting tip 20 to cleanly pierce the skin asit extends outwardly through abdomen without stretching or tearing ofthe skin. As such, the alignment guide arm 14 allows the surgeon toreadily identify the precise location of the cutting tip 20 while in itsblind location within the bladder 18, thereby enabling the surgeon topuncture a surgical pathway, referred to hereafter as an opening 24,through the bladder 18 and the abdomen wall 22 at a precise and intendedlocation. Accordingly, the surgeon is provided with an increased levelof confidence that the opening 24 formed by the cutting tip 20 is at thedesired location, will be clean without tearing, and is further assuredthat inadvertent damage to internal organs, such as the bowel, isavoided. Upon forming the opening 24, a catheter 26 (FIG. 14) or othersurgical instrument can be inserted through the opening 24 and into thebladder 18, depending on the nature of the procedure being performed.Further, the alignment guide arm 14 not only provides a precise exitlocation for the cutting tip 20, but it can also be used to establish aprecise linear path along which to form the opening 24 using anoutside-in cut, such as by using an external trocar punch, for example,and extending the external trocar along a line established by thealignment guide arm 14, discussed further below.

As best shown in FIGS. 1 and 2, the sound 12 has a proximal portion 28and a distal portion 30, with the distal portion 30 being configured forinsertion into the bladder 18 through the urethra 16 (e.g., FIG. 8). Theproximal portion 28 and the distal portion 30 have respective linearsections that are inclined relative to one another at a predeterminedand generally fixed obtuse angle of inclusion 32, such that the anglebetween the respective linear sections remains generally fixed in use.The proximal portion 28 can have measured indicator markings 33 toindicate to the surgeon the depth of insertion of the sound 12 into theurethra 16. In addition, a penetration depth marker, also referred to asan indicator slide 35 can be disposed on the proximal portion 28 toassist in identifying the depth and location of the sound 12 within thebladder 18 during the procedure. The sound 12 is constructed from amaterial that can be readily sterilized, such as stainless steel, by wayof example and without limitation. It should be recognized that othermaterials which can be readily sterilized are contemplated andincorporated herein within the scope of the invention, includingplastics materials, for example. The sound 12, although constructed froma material capable of being sterilized, is preferably constructed as adisposable, single use instrument.

The proximal portion 28 is fixedly connected to a front handle 34 whichhas a straight, tubular body 36 extending rearwardly away from the sound12 to an end 38. The front handle 34 provides a reliable and comfortablelocation for grasping and manipulating the sound 12. The front handle 34can be provided having any suitable shape and configuration, dependingon the requirements of the surgeon. For example, the front handle 34 canbe ergonomically designed for left and right handed physicians anddesigned for optimal manipulation, control and orientation of the sound12 while preventing hand slippage when wet and in contact with surgicalgloves. Accordingly, it is contemplated that the front handle 34 can beprovided having different shapes and contours, as desired. The fronthandle 34 and tubular body 36 can be molded as single piece halves andthen subsequently joined, such as via fasteners, an adhesive or viawelding, for example. Of course, the front handle 34 and tubular body 36can be formed using any suitable plastic or metal materials andprocesses.

The front handle 34 has an upstanding housing, referred to hereafter asmount sleeve 40, configured for releasable attachment of a straightslide arm, referred to hereafter as mast 42, thereto. As best shown inFIG. 2, the mount sleeve 40 has a pocket 44 sized for close receipt ofone end 46 of the mast 42 therein. To facilitate fixing the end 46 ofthe mast in the pocket 44, the mount sleeve 40 has a releasable mastlocking mechanism 48, represented here, by way of example and withoutlimitation, as an over-center cam latch lever 50. The cam latch lever 50has a cam surface 52 that frictionally engages the mast 42 when thelever 50 is in a depressed, locked position, thereby maintaining themast 42 in a fixed position within the pocket 44. Otherwise, when thelever 50 is pivoted to a raised, unlocked position, the cam surface 52is moved out of engagement with the mast 42, thereby allowing the mast42 to be removed from the pocket 44. The pocket 44 is configured toextend along a straight, linear axis 54, whereby the mast 42, upon beinglocked within the pocket 44 also extends along the axis 54. The axis 54is oriented to extend substantially parallel to the distal portion 30 ofthe sound 12. Accordingly, upon fixing the mast 42 in the mount sleeve40, the mast 42 and the distal portion 30 of the sound 12 extendparallel or substantially parallel to one another. The angle of the mast42 extending from the front handle 34 is configured to properly alignthe alignment guide arm 14 and a capture cup assembly 96 in the properposition to accept the cutting tip 20. This is of great assistance tothe surgeon, as the surgeon otherwise would not have a visual locationof the cutting tip 20 when inside the bladder 18.

As best shown in FIGS. 5 and 6, the front handle 34 further includes acutting tip locking mechanism 56, represented here, by way of exampleand without limitation, as having a rotatable brake knob or wheel 58, acam member 60 fixed to the wheel 58 for conjoint rotation therewith,such as by being formed as a single piece of material therewith, and aspring member, referred to hereafter as a brake spring 62. When thewheel 58 is rotated to a locked position, the cutting tip 20 is fixedagainst relative movement with the sound 12, and when rotated to anunlocked position, the cutting tip 20 is movable relative to the sound12, discussed further below.

The tubular body 36 extends rear-ward from the rear of the front handle34 a predetermined distance sufficient to provide the range of movementof the cutting tip 20 desired. It should be recognized that the range ofmovement of the cutting tip 20 will generally be less for a normal sizedpatient than for an obese or morbidly obese patient, and that the rangeof movement of the cutting tip 20 can be provided to accommodate anysize patient. The tubular body 36 has tubular wall with an elongate slot64 extending along its length, wherein the length of the slot 64corresponds at least to the desired distance of travel of the cuttingtip 20. The slot 64 is represented here as extending of the full lengthof the tubular body 36 along a bottom side thereof. The wall of thetubular body 36 is also represented, by way of example and withoutlimitation, as having an upstanding rib 66 extending along an upper sideof the wall diametrically opposite the slot 64. The upper side of thetubular wall preferably has measured scale markings 67 to indicate tothe surgeon the distance the cutting tip 20 is extended, discussedfurther below.

The apparatus 10 further includes an advancement member 68, representedhere as a flexible coil rod or flat spring member, with a distal end 70being operably attached to the cutting tip 20 and a proximal end 72being attached to a rear handle 74 of the apparatus 10. The distal end70 is represented here as having a connector 71 for selective,releasable attachment of the cutting tip 20 thereto. As best shown inFIG. 7, the connector 71 is a modified bayonet-type connector, forexample, having at least one ramped, spiral shaped entry slot 73terminating at a recessed lock detent. The proximal end 72 is fixed tothe rear handle 74, such as by generally narrow connector plate 78 sizedto slide through the slot 64. The connector plate 78 can be fixed to theadvancement member 68, such as by a weld joint, for example, and to therear handle 74 via a fastener 80, for example. Accordingly, movement ofthe rear handle 74 causes conjoint movement of the connector plate 78and the advancement member 68.

The advancement member 68 can be provided of any suitable materialflexible enough to traverse the bend in the sound 12 between theproximal portion 28 and the distal portion 30, while being rigid enoughto maintain a straight cutting path through the bladder 18 and abdominalwall 22, such as stainless steel or spring steel, for example. Theadvancement member 68 can further be provided as a single piece ofmaterial or multiple pieces of material joined to one another. Theadvancement member 68 has a plurality of circumferential notches 76spaced in axially uniform relation from one another along a proximal orrear portion thereof for operable locking engagement with the brakespring 62. Preferably, the notches 76 extend over the full portion thattraverses beneath the cutting tip lock mechanism 56, thereby allowingthe cutting tip 20 to be locked in a fully retracted position and in afully extended position, as well as over a plurality of locationsbetween the fully retracted and extended positions.

The rear handle 74 can be provided having any suitable shape andconfiguration. For example, the rear handle 74 can be ergonomicallydesigned for left and right handed physicians and designed for optimalmanipulation, control and orientation of the advancement member 68 andcutting tip 20 while preventing hand slippage when wet and in contactwith surgical gloves. The rear handle 74 can be molded as single piecehalves, with the halves being subsequently joined, such as viafasteners, an adhesive or via welding, for example, and can be formedusing any suitable plastic or metal materials and processes. As shown inFIGS. 2-4, the rear handle 74 is formed having a through passage 82sized for close sliding receipt over the tubular body 36. The passage 82can be provided with a recessed notch 84 sized to slidingly receive theupstanding rib 66 therein, thereby preventing rotation of the rearhandle 74 about the tubular body 36. This prevents unwanted rotation ofthe cutting tip 20 while forming the opening through the tissue.

The mast 42 has a straight, elongate body 86 extending between the end46 received in the pocket 44 of the front handle 34 and an opposite end87. The body 86 preferably has measured scale markings 88 to facilitateindicating to the surgeon the distance over which the cutting tip 20generally needs to extend through the abdomen of the patient. The body86 can be formed as a solid body or a hollowed body using any desiredprocess, such as extrusion, for example, and can be formed of anysuitable polymeric or metal material, as desired. The body 86 isrepresented here as being generally rectangular in lateralcross-section, which assists in maintaining the alignment guide arm 14in its proper orientation by preventing unwanted relative pivotingbetween the arm 14 and the positioning mast 42, although anycross-sectional geometry could be used. The body 86 can be provided ofany suitable length, and preferably has a length between about 15-20inches, thereby allowing suitable adjustment of the alignment guide arm14 on morbidly obese patients.

The alignment guide arm 14 has body 90 that extends between a first end92 and a second end 94. The first end 92 is configured for operableattachment to the proximal portion 28 of the sound 12 and for slidingreceipt along the mast 42. The second end 94 is configured forattachment to the capture cup 96. The first end 92 has a through opening98 configured for close sliding receipt of the mast body 86.Accordingly, the through opening 98 is shaped having a similarcross-sectional geometry as the mast body 86, though being slightlylarger to facilitate sliding movement along the mast body 86. Tofacilitate releasable locking of the alignment guide arm 14 in a desiredfixed position along the mast body 86, the first end 92 has a releasablearm locking mechanism 100, represented here, by way of example andwithout limitation, as an over-center cam latch lever 102. The cam latchlever 102 has a cam surface 104 that frictionally engages the mast 42when the lever 102 is in a depressed, locked position, therebymaintaining the alignment guide arm 14 in a fixed position along themast body 86 at the desired position. Otherwise, when the lever 102 ispivoted to a raised, unlocked position, the cam surface 104 is moved outof engagement with the mast body 86, thereby allowing the alignmentguide arm 14 to be slid freely along the length of the mast body 86.

The second end 94 of the alignment guide arm 14 has a semi-annular orannular housing 106 providing a through passage 108 of a predetermineddiameter that extends along an axis 110 that is coaxial with the distalportion 30 of the sound 12 when then alignment guide arm 14 is attachedto the mast 42, and the mast 42 is received in the mount sleeve 40. Thehousing 106 is further represented here as the indicator, by way ofexample and without limitation, as having an upper surface with one ormore lateral slots 112 configured to releasably receive the capture cup96. As shown in FIG. 13A, to facilitate guiding the cutting tip 20 intothe capture cup 96, the through passage 108 of the housing 106 can beprovided having a funnel shape with an enlarged diameter 114 locatedadjacent a bottom surface of the housing 106 and a reduced diameter 116located adjacent the upper surface of the housing 106.

The capture cup 96 has a closed upper portion 118 configured to beeasily grasped and rotated, and is represented here, by way of exampleand without limitation, as having a generally rectangular wall withopposite sides easily graspable between a thumb and index finger. Asbest shown in FIGS. 13A and 13B, a generally cylindrical, annular wall120 depends from the upper portion 118, wherein the annular wall 120 issized for close sliding receipt in the housing 106 of the alignmentguide arm 14. Further, the capture cup 96 has one or more fingers 122extending laterally outwardly for sliding receipt in the slots 112 ofthe housing 106. The fingers 122 extend outwardly to engage the uppersurface of the housing 106, and are received in the slots 112 byrotating the capture cup 96 relative to the housing 106. Accordingly,upon rotating the capture cup 96 in one direction, the fingers 122 slidein the slots 112 and engage a bottom surface of the slots 112, whereinthe capture cup 96 is releasably locked to the housing 106, and uponrotating the capture cup 96 in the opposite direction, the fingers 122exit the slots 112, wherein the capture cup 96 can be removed from thehousing.

To facilitate capturing the cutting tip 20 in the capture cup 96, a boreor cavity of the capture cup 96 can be provided with an annularelastomeric wall or sleeve 124, such as an silicone tubing, for example,wherein the sleeve 124 has a slightly reduced diameter from the outerperiphery of the cutting tip 20 to cause the cutting tip 20 to cut intothe sleeve 124 upon being inserted therein, thereby being capturedwithin the capture cup 96 for hands free disposal. To provide assurancethat the cutting tip 20 in fully inserted in the capture cup 96, a stopsurface 125 can be provided to abut the cutting tip 20, thereby actingas a positive stop to limit the distance the cutting tip 20 can beinserted into the capture cup 96. Although the capture cup 96 is shownhaving the fingers 122 for releasable receipt in the slots 112, otherattachment mechanisms are contemplated herein, such as a threadedattachment or the capture cup could be formed as a single piece ofmaterial with the alignment guide arm 14. To further facilitatereleasing the cutting tip 20, a plurality of ribs can extend radiallyinwardly from the inner surface of the sleeve 124 to provide a bearingsurface against the flat cutting blade as a ‘stop’ when rotating thecapture cup 96. This further assures the cutting tip 20 will be rotatedconjointly with the capture cup 96 while rotating the capture cup 96.

As best shown in FIGS. 7, 13A and 13B, the cutting tip 20 is constructedhaving a metal cutting member 126 and a connector 128 dependingtherefrom. The cutting member 126 is illustrated as having one or moreopenings 130 to facilitate attachment of the cutting member 126 to theconnector 128. The connector 128 can be formed of an polymeric material,and further, can be molded, such as in an injection molding process, forexample, to the cutting member 126. The connector 128 has acorresponding number of bayonets or fingers 132 extending laterallyoutwardly for sliding receipt in the ramped slots 73 in the connector71. The fingers 132 are configured to lock releasably in the slots 73 bydeflecting into recessed detents at the end of the ramped slots 73, andto deflect out of the detents upon applying a suitable torque to thecutting member 126, which can be applied via rotation of the capture cup96 when the cutting tip 20 is captured therein. The cutting tip 20 canbe initially enclosed within a counterbore 133 in the distal end of thesound 12 and/or covered by a relatively soft sheath 134, such as a softpolymeric material attached in flush relation on a reduced outerdiameter portion 135 of the distal end portion, e.g. rubber or silicone,to protect the cutting blades of the cutting member 126 and to preventthe inadvertent cutting of tissue while inserting the sound 12 throughthe urethra 16. Upon moving the cutting tip 20 axially outwardly fromthe sound 12, the cutting tip 20 can readily penetrate the relativelysoft sheath to expose the cutting tip 20 for penetrating through thebladder 18 and out the abdomen wall 22.

As shown in FIG. 14A, the catheter 26 has a first end 136 configured foroperable attachment to the sound 12 via the connector 71 on theadvancement member 68 and a second end 138 configured for operableattachment to a fluid collection system. As best shown in FIG. 14C, thefirst end 136 has a bayonet-type connector 140 configured generally thesame as the connector 128 on the cutting tip 20, thereby beingattachable and removable via relative rotation, however, as shown inFIG. 14D, the rear of the connector 140 has a non-circular pocket, suchas a square pocket 141, for example. The pocket 141 facilitates removingthe catheter 26 from the connector 71 of the advancement member 68 via aremove tool 143 having a appropriately shaped removal rod end 145 (FIG.14E) conforming to the shape of the pocket 141. Accordingly, the rod end145 here has a square cross-sectional shape. To prevent inadvertent harmto tissue from the connector 140, a shroud 142 is attached to the end136 of the catheter 26, with the shroud 142 overlying the connector 140to provide a substantially smooth and soft outer surface about theconnector 140. An annular space 143 is provided between the connector140 and the shroud 142 to allow the connector 71 on the advancementmember 68 to be received for attachment to the connector 140 on thecatheter 26. The catheter 26 has an inflatable balloon 144 near thefirst end 136 to selectively maintain the catheter 26 within the bladder18, and at least one opening 146, represented here by way of example andwithout limitation as being oval, between the balloon 144 and the firstend 136 to provide entry for fluid into the catheter 26 for drainage ofthe fluid within the bladder 18 through the catheter 26. In addition,the catheter 26 is adapted for releasable attachment of a tether 148thereto, wherein the tether 148 can be provided as a loop of suturematerial, for example.

As shown in FIG. 8, the inside-out suprapubic transurethral procedure isinitiated by inserting the distal portion 30 of the sound 12 through theurethra 16 and into the bladder 18. During insertion of the sound 12through the urethra 16, the cutting tip 20 is covered with the sheath134 to prevent inadvertent damage from occurring to the urethra 16. Themast 42 can be inserted and locked in the mount sleeve 40 and thealignment guide arm 14 can be slid onto the mast 42 and temporarilylocked in the desired position via the mast locking mechanism 48.

With the alignment guide arm 14 positioned over the abdominal wall 22,an outside-in procedure could be performed, if desired, given thealignment guide arm 14 provides a path directly into the bladder 18.Accordingly, an external trocar punch could be pushed along the axis 110indicated by the housing 106 through the abdominal wall 22 and into thebladder 18. Otherwise, if performing an inside-out procedure, thecapture cup 96 is attached to the housing 106, and the tip or free endof the distal portion 30 is positioned against the inside surface of thebladder 18, generally about 1-2 finger widths above a pubic bone 152, toestablish a slight “tenting” of the bladder 18 and abdominal wall 22, asshown in FIG. 9. The tenting facilitates moving the bowel away from thedistal portion 30 of the sound 12, and thus, away from the cutting tip20. With the exception of obese to morbidly obese patients, the tentingis generally observable externally by the surgeon.

Next, as shown in FIG. 10, the alignment guide arm 14 can be releasedfrom the locked position on the mast 42 and lowered into compressingengagement with the outer skin surface of the abdominal wall 22. Withthe housing 106 of the alignment guide arm 14 properly positionedagainst the abdomen wall 22, the mast locking mechanism 48 can again belocked, thereby maintaining the apparatus 10 in the desired position.

Then, as shown in FIG. 11, upon locking the alignment guide arm 14 inthe desired location over the abdomen wall 22, the penetration depthmarker 35 can be moved forward to the opening of the urethra 16 toprevent further movement of the sound 12. The measurement or indicatormarkings 33 can be observed by the physician.

Next, as shown in FIG. 12, the cutting tip 20 can be advanced topenetrate through the protective sheath 134, through the bladder 18 andthrough the abdominal wall 22. This is performed by rotating the wheel58 of the cutting tip locking mechanism 56 from the locked position tothe unlocked position, thereby biasing the brake spring 62 out ofengagement with the respective notch 76 in the advancement member 68.Accordingly, the advancement member 68 is free to slide within thetubular body 36 and the sound 12 upon pushing on the rear handle 74. Asthe rear handle 74 is pushed, the surgeon is able to visually see fromthe scaled markings 67 on the tubular body 36 how far the advancementmember 68, and thus, the cutting tip 20, is being advanced. In addition,the surgeon can readily determine an indication of the distance from theinside of the bladder wall 18 to the outside of the abdomen wall 22 viathe measured markings 88 on the mast, and thus, the surgeon knowsgenerally how far the cutting tip 20 must be advanced to penetrate theabdomen wall 22. While being advanced outwardly from the sheath 134 andoutwardly, away from the sound 12, the advancement member 68 remainsrigid along the length extended away from the sound 12 to allow it topenetrate the abdomen wall 22 in a controlled and substantially straightpath such that it remains in constant coaxial alignment with the housing106 of the alignment guide arm 14 and the capture cup 96.

As shown in FIGS. 13 and 13A, the cutting tip 20 is then advanced intoand captured in the capture cup 96 of the alignment guide arm 14,whereupon the cutting tip 20 can be released in a hands-free procedureand then disposed as captured in the capture cup 96 (FIG. 13B).

As shown in FIG. 13B, upon the cutting tip 20 being captured in thereceptacle 96 and released from the sound 12, the alignment guide arm 14can then be detached from the mount sleeve 40. Then, as shown in FIG.14, the end 136 of the catheter 26 can be attached to the connector 71on the end of the advancement member 68. As shown in FIG. 15, with thecatheter 26 operably attached to the sound 12 via the advancement member68, the catheter 26 can be pulled into the bladder by withdrawing thesound 12 from the urethra 16 and/or by withdrawing the advancementmember 68 via pulling on the rear handle 74. The depth marker 35 on thesound 12 located at the opening of the urethra 16 can assist the surgeonin identifying how far the sound 12 needs to be withdrawn in order toensure the end 136 and balloon 144 of catheter 26 are locatedsufficiently within the bladder 18 prior to inflating the balloon 144.

As shown in FIG. 16, with the sound 12 and/or advancement member 68having been drawn a sufficient distance outwardly from the urethra 16 toensure the catheter 26 is received properly in the bladder 18, as notedby the distance between the urethra opening and the penetration depthmarker 35, the balloon 144 of the catheter 26 is inflated with fluid viaa syringe at or adjacent to the second end 84 of the catheter 26.

As shown in FIG. 17, the inflated balloon 144 is then manipulated intoseated engagement with the surgically cut opening in the bladder 18 bypulling or otherwise withdrawing the catheter 26 slightly outwardly fromthe abdominal wall 22, while still attached to the advancement member68.

Then, as shown in FIG. 18, once the surgeon has verified that theballoon 144 is properly seated against the inner surface of the bladderwall 18, and that proper drainage is flowing through the catheter 26,catheter 26 is detached from the advancement member 68, and the sound 12is then gently withdrawn from the urethra 16. As discussed above, thedetachment of the catheter 26 from the advancement member 68 isfacilitated by use of the removal tool 143. By inserting the rod of theremoval tool 143 through the length of the catheter 26, and insertingthe appropriately configured rod end 145 into the pocket 141 of theconnector 140, the removal tool 143 can be rotated in thecounter-clockwise direction to impart relative rotation between theconnectors 71, 140, thereby causing the catheter to become disconnectedfrom the advancement member while the connectors 71, 140 are in thebladder 18. Meanwhile, though the sound 12 and advancement member 68 arefree for removal through the urethra 16, the catheter 26 remainspartially deployed in the bladder 18 with the balloon 144 in seatedengagement with the inner surface of the bladder wall 18.

Obviously, many modifications and variations of the present inventionare possible in light of the above teachings. It is, therefore, to beunderstood that within the scope of the appended claims, the inventionmay be practiced otherwise than as specifically described.

What is claimed is:
 1. A suprapubic transurethral cystotomy apparatusused to create a surgical pathway from a bladder through an abdomen of apatient, comprising: an elongate hollow tubular body including aproximal portion and a distal portion inclined relative to one another,said distal portion adapted to be inserted through a urethra and intothe bladder, said proximal portion adapted to remain outside of theurethra for manipulation of the distal portion into the urethra andwithin the bladder, said distal portion including a linear sectionextending along a linear axis and terminating at a distal end of thedistal portion; an advancement member positioned within the tubular bodyfor advancing and retracting movement, the advancement member having adistal end and a proximal end respectively located at the distal end andat the proximal end of the tubular body, the distal end of theadvancement member extending out from the distal end of the tubular bodyin a linear path along the axis of the linear section of the distalportion of the tubular member to create the surgical pathway from thebladder through the abdomen with sufficient advancing movement of theadvancement member while the distal end of the distal portion of thetubular body is located adjacent to a wall of the bladder; an indicatorfor indicating the axis of the linear section of the distal portion ofthe tubular body; and an alignment structure adapted to be locatedoutside of the patient and operably attached between said proximalportion of said tubular body and said indicator, said alignmentstructure positioning the indicator in coaxial alignment with said axisof the linear section of said distal portion of said tubular body andpermitting adjustable movement of the indicator along a range ofdistances along said axis relative to the distal end of the distalportion of the tubular body while maintaining said coaxial alignment. 2.The apparatus of claim 1 further including: a cutting tip attached tothe distal end of the advancement member and extending from said distalend of said tubular body upon advancing movement of the advancementmember.
 3. The apparatus of claim 2 further including: a handle attachedto the proximal end of said advancement member at the proximal end ofsaid tubular body for imparting the advancing and retracting movement ofthe advancement member.
 4. The apparatus of claim 3 further including: alocking mechanism connected to the proximal portion of said tubular bodyand movable between a locked position to prevent the advancing andretracting movement of said advancement member within said tubular bodyand an unlocked position to allow the advancing and retracting movementof said advancement member within said tubular body.
 5. The apparatus ofclaim 4 wherein: said advancement member has a plurality of notchesspaced from one another along said advancement member and said lockingmechanism includes a spring member movable into said notches in saidlocked position and out of said notches in said unlocked position. 6.The apparatus of claim 1 wherein said alignment structure includes: astraight mast operably attached to the proximal portion of said tubularbody, body to extend generally parallel to the linear section of thedistal portion of said tubular member; and an elongate arm having afirst end and a second end, the first end connected to said mast to movealong said mast, the second end connected to said indicator; andwherein: the parallel orientation of said mast with the linear sectionof the distal portion of said tubular member and the movement of saidelongate arm along said mast maintaining said coaxial alignment of theindicator with the axis along the range of distances.
 7. The apparatusof claim 6 further including a handle attached to said proximal portionof the tubular body for manipulating the distal portion of the tubularbody within the urethra and the bladder, said handle having a mountsleeve to receive and orient said mast to extend generally parallel tothe linear section of the distal portion of said tubular member.
 8. Theapparatus of claim 2 wherein said indicator includes: a cup having acavity coaxially aligned with said axis to receive said cutting tiptherein upon advancing movement of the advancement member after creatingthe surgical pathway.
 9. The apparatus of claim 8 wherein: said cupincludes an elastomeric wall which surrounds the cavity, and saidcutting tip cuts into said wall upon receiving said cutting tip in saidcavity.
 10. The apparatus of claim 2 wherein: said distal end of saidadvancement member and said cutting tip include complementary connectorparts of a connector structure for releasably connecting said cuttingtip to the distal end of said advancement member.
 11. The apparatus ofclaim 10 further comprising, in combination: a catheter having a distalend which includes a complementary connector part of the connectorstructure for releasably connecting the distal end of the catheter tothe complementary connector part of the connector structure at saiddistal end of said advancement member.
 12. The apparatus of claim 11wherein the complementary parts of said connector structure on saiddistal end of said catheter and the distal end of the advancement memberconstitute a bayonet type connector.
 13. The apparatus of claim 12further comprising in combination: a tool for insertion into thecatheter to contact said bayonet type connector; and wherein: thecomplementary parts of said bayonet type connector are releasable fromone another to disconnect the distal end of the catheter from the distalend of the advancement member by manipulation of said tool insertedthrough said catheter and in contact with the bayonet type connectorwhile the bayonet type connector is in the bladder.
 14. The apparatus ofclaim 2, further including: a sheath extending across the distal end ofthe distal portion of the tubular body and enclosing the cutting tipwithin the tubular body, the sheath formed of material which ispenetrated by the cutting tip upon advancing movement of the advancementmember to move the cutting tip to create the surgical pathway.
 15. Theapparatus of claim 5, wherein the advancement member comprises aflexible coil.
 16. The apparatus of claim 5, wherein the advancementmember comprises a flat spring member.
 17. The apparatus of claim 6,further including: markings on said mast which indicate the distancebetween the distal end of the distal portion of the tubular body and theindicator, when the indicator is contacted with the exterior abdomen andthe distal end of the distal portion of the tubular body contacts a wallof the bladder.
 18. The apparatus of claim 17, further including:markings at said proximal portion of said tubular body which indicate anamount of advancing movement of the advancing member from the distal endof the distal portion of the tubular body to create the surgicalpathway.
 19. The apparatus of claim 6, wherein: the first end of saidelongate arm includes a locking mechanism which maintains said elongatearm in a fixed position relative to said mast when locked and whichreleases said elongate arm for movement along said mast when unlocked.20. The apparatus of claim 6, wherein: said elongate arm moves alongsaid mast over a range of distances which permits the second end of saidelongate arm to clamp against an exterior abdominal wall of the patientand apply tensile reinforcement to exterior abdominal skin of thepatient while creating the surgical pathway.
 21. The apparatus of claim6, further comprising: an open ended receptacle formed on the first endof said elongate arm, the receptacle having an interior surface whichdefines an interior conduit through which said mast is slidablyreceived; and a latch mechanism attached to the open ended receptacle,the latch mechanism having a locked position which inhibits relativemovement between the first end of said elongate arm and said mast bypressing the mast against the interior surface of the receptacle, thelatch mechanism also having an unlocked position which does not inhibitthe relative movement between the first end of said elongate arm andsaid mast.
 22. the apparatus of claim 7, wherein: the sleeve mountreleasably receives said mast therein; and further including: a lockingmechanism which maintains the mast in a fixed position within the sleevemount when locked and which releases the mast from the sleeve mount fordisconnection from the proximal portion of said tubular body whenunlocked.
 23. The apparatus of claim 8, wherein the indicator furtherincludes: a housing; and wherein: the cup is releasably attachable tothe housing.
 24. The apparatus of claim 9, wherein the indicator furtherincludes: a housing defining an annular passage that is coaxial withsaid axis and extends along said axis; and wherein: the cup isreleasably attachable to the housing at the annular passage with thecavity coaxially aligned with the annular passage.
 25. The apparatus ofclaim 24, wherein: the cup is releasably attachable to and detachablefrom the housing by rotational movement; the cutting tip is releasablyconnectable to and disconnectable from the distal end of the advancementmember by rotational movement; the cutting tip is retained by saidelastomeric wall upon cutting into said elastomeric wall upon receipt ofthe cutting tip in said cavity; and releasing the cup from the housingwith rotational movement simultaneously disconnects the cutting tip fromthe distal end of the advancement member with the same rotationalmovement.
 26. The apparatus of claim 25, wherein: the passageway in thehousing and the elastomeric wall of the cup are funnel shaped to directthe cutting tip toward the axis upon advancing movement into thepassageway and the cup.
 27. The apparatus of claim 11, furtherincluding: markings on said tubular body along the adjoining distal andproximal portions of said tubular body to indicate the distance towithdraw the tubular body from the urethra for positioning the connectorstructure within the bladder.
 28. The apparatus of claim 11, furtherincluding: a shroud formed around the distal end of said catheter andoverlying the complementary connector part of the connector structure onthe distal end of the catheter.